US20050004592A1 - Balloon dissector with balloon tip cannula - Google Patents

Abstract

There are disclosed various embodiments of a combined balloon dissector with balloon tip cannula which are provided to facilitate forming an anatomical space within the body, such as, for example, an anatomical space in the abdominal cavity or extraperitoneal space for facilitating hernia repair surgeries. The combined balloon dissectors with cannula generally include a cannula assembly for anchoring the device to the abdominal wall and a dissector assembly having a dissection balloon at a distal end for separating tissue layers and forming an anatomical space. Various combinations of valve ports and sub-assemblies are disclosed for providing inflation fluid to the balloon tip cannula, and inflation fluid for the dissection balloon.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Provisional Application Ser. No. 60/468,919, filed May 8, 2003, the disclosure of which is hereby incorporated by reference.
BACKGROUND
• 1. Technical Field
• The technical field relates to balloon dissectors for forming an anatomical space within a body, to cannulas having balloon anchors, and to apparatus having a combined balloon dissector and balloon tip cannula.
• 2. Background of Related Art
• During various surgeries, it is necessary to dissect tissue layers to form an anatomical space within which surgical instruments may be manipulated. For example, in hernia repair surgery, it is necessary to form an anatomical operative cavity within the extraperitoneal space in order to dissect fascia tissue layers and access the hernia site. Various balloon dissectors are known for performing the tissue dissection procedure used in hernia repair surgery. These generally include a single device having a dissection balloon formed on the distal end of a tube and an inflation port formed on the proximal end of the tube. The balloon dissector is inserted into an incision and the balloon is inflated for dissection. After dissection and after removing the balloon dissector from the incision, a cannula is inserted into the incision and used to insufflate while forming an access passageway for the introduction of surgical instruments into the anatomical space.
• While the currently known tissue dissection devices and cannulas are useful, improvements are desirable. It would be beneficial to have a balloon dissector device combined with a balloon tip cannula.
SUMMARY
• There is disclosed a balloon dissector assembly for creating an anatomical space within a body and a balloon tip cannula assembly for providing an access port into the body. The balloon dissector assembly and the balloon tip cannula assembly can be used separately as stand alone instruments or, preferably, as a combined balloon dissector and balloon tip cannula. Notably components on both devices allow them to be easily combined.
• In an aspect of the present invention, a balloon dissector and balloon tip cannula assembly comprises: a balloon dissector including a dissector tube defining a passage and a dissection balloon having an interior and being affixed to a distal end of the dissector tube so that the passage and the interior communicate with one another; an obturator configured for insertion through the passage; a balloon tip cannula having a cannula tube receiving the balloon dissector, the cannula tube having a distal end and an anchoring balloon at the distal end; and an adapter having a dissection inflation port in communication with the passage for inflating the dissection balloon, an anchor inflation port in communication with the anchoring balloon, and an insufflation port in communication with the cannula tube.
• In a further aspect of the present invention, a balloon dissector and balloon tip cannula assembly comprises: a balloon dissector including a dissector tube defining a passage and a dissection balloon having an interior and being affixed to a distal end of the dissector tube so that the passage and the interior communicate with one another; an obturator configured for insertion through the passage and into the interior of the dissection balloon; and a balloon tip cannula having a cannula tube receiving the balloon dissector, the cannula tube having a distal end and an anchoring balloon at the distal end.
• In certain preferred embodiments, the balloon dissector has an inflation port arranged for providing inflation fluid to the passage. The balloon dissector may include latching structure to releasably retain the balloon tip cannula. Additionally or in the alternative, the balloon tip cannula may include latching structure to releasably retain the balloon dissector.
• In certain embodiments, the balloon dissector has a removable shroud arranged to cooperate with the latching structure on the balloon tip cannula. In certain preferred embodiments, an inner surface of the dissector tube and an outer surface of the obturator defines an inflation lumen therebetween for inflating the dissection balloon. The balloon dissector may also include a dissector inflation valve so that the inflation lumen communicates between the dissector inflation valve and the dissection balloon.
• In certain preferred embodiments, the assembly includes a separable securing sleeve arranged to retain the dissection balloon in an initial collapsed configuration.
• In a further aspect of the present invention, a balloon dissector assembly, comprises: a balloon dissector including a dissector tube defining a passage and a dissection balloon having an interior and being affixed to a distal end of the dissector tube so that the passage and the interior communicate with one another; and an obturator configured for insertion through the passage and being arranged with the dissector tube so as to form an inflation lumen communicating with the interior of the balloon.
• In a further aspect of the present invention, a balloon dissector assembly comprises: a balloon dissector including a dissector tube defining a passage and a dissection balloon having an interior and being affixed to a distal end of the dissector tube so that the passage and the interior communicate with one another and so that the dissection balloon extends from the distal end of the dissector tube; and an obturator configured for insertion through the passage and into the interior of the dissection balloon so that the dissection balloon is supported on the obturator.
• In certain preferred embodiments, the assembly includes a separable securing sleeve arranged to retain the dissection balloon in an initial collapsed configuration on the obturator. The balloon dissector may also have an inflation port arranged for providing inflation fluid to the passage. The inflation fluid is desirably communicated to the dissection balloon. As the balloon starts to expand, a weakened region of the sleeve separates to release the dissection balloon. The expanded dissection balloon preferably forces tissue layers apart along natural tissue planes to create an anatomical space.
• In certain preferred embodiments, an inner surface of the dissector tube and an outer surface of the obturator defines an inflation lumen therebetween. A proximal end of the balloon dissector desirably includes an orifice in communication with the passage so that upon removal of the obturator from the dissector tube, the dissection balloon deflates. The balloon dissector desirably includes a dissector inflation valve and the inflation lumen communicates between the dissector inflation valve and the dissection balloon.
• In a further aspect of the present invention, a method of creating an anatomical space within a body for use in surgery comprises forming an incision in the body and inserting a balloon dissector assembly through the incision to a desired position. The balloon dissector assembly comprises: i) a balloon dissector including a dissector tube defining a passage and a dissection balloon having an interior and being affixed to a distal end of the dissector tube so that the passage and the interior communicate with one another; and ii) an obturator configured for insertion through the passage and being arranged with the dissector tube so as to form an inflation lumen communicating with the interior of the balloon. The method includes: inflating the dissection balloon by introducing inflation fluid through the inflation lumen, so as to force tissue layers apart along natural tissue planes to create an anatomical space; and deflating the balloon.
• In a further aspect of the present invention, a method of creating an anatomical space within a body for use in surgery comprises forming an incision in the body and inserting a balloon dissector assembly through the incision to a desired position. The balloon dissector assembly comprises: i) a balloon dissector including a dissector tube defining a passage and a dissection balloon having an interior and being affixed to a distal end of the dissector tube so that the passage and the interior communicate with one another and so that the dissection balloon extends from the distal end of the dissector tube; and ii) an obturator configured for insertion through the passage and into the interior of the balloon so that the dissection balloon is supported on the obturator. The method includes the step of inserting including tunneling through tissue with the obturator; inflating the dissection balloon so as to force tissue layers apart along natural tissue planes to create an anatomical space; and deflating the balloon.
• In certain preferred embodiments, the obturator and dissector tube define an inflation lumen therebetween and the method includes introducing inflation fluid into the inflation lumen so as to inflate the dissection balloon. The method may include removing the obturator before the step of inflating and inserting an instrument into the passage. The instrument may comprise an endoscope.
• In certain preferred embodiments, the obturator is removed after the step of inflating so as to deflate the dissection balloon. The balloon dissection assembly may include a separable securing sleeve arranged to retain the dissection balloon in an initial collapsed configuration and the step of inflating the dissection balloon may include separating the sleeve.
• In certain preferred embodiments, the balloon dissector assembly is inserted into the abdomen and a hernia in the abdomen is repaired.
• In another aspect of the present invention, an assembly for providing subcutaneous access to a body cavity comprises: a balloon tip cannula having a cannula tube and an anchoring balloon on a distal end of the cannula tube, the balloon tip cannula having an anchor inflation port and a lumen in communication with the anchoring balloon, the balloon tip cannula having an insufflation port for providing insufflation fluid to the body cavity; an obturator received in the cannula tube; the balloon tip cannula having an adapter on a proximal end thereof, the adapter and the obturator being arranged for connecting the obturator and the balloon tip cannula, the adapter having at least one seal disposed within the adapter and being arranged to attach to a device to be received in the cannula tube after the obturator is removed from the cannula tube.
• There is disclosed a novel method of securing a balloon anchor to a tube which includes the steps of dipping a selective region of the tube in a suitable material, for example, urethane, and positioning the inflatable balloon anchor about the selective region. Thereafter, opposed ends of the inflatable balloon anchor may be subjected to a thermal weld to weld the opposed ends to the coated selective region. There may be additionally provided a silicone sleeve positionable over the inflatable balloon anchor and secured thereto by means of heat shrink rings applied to opposed ends of the silicone sleeve.
• In certain preferred embodiments, the cannula tube has a wall and a lumen is defined in the wall, the lumen communicating with the anchor inflation port and the anchoring balloon. A skin seal may be movably mounted on the cannula tube. The skin seal may include structure for securing the skin seal at a desired longitudinal location on the elongated tube.
• In certain preferred embodiments, the at least one seal includes a first seal for sealing the cannula tube in the absence of an instrument being received within the cannula tube. The at least one seal may also include a second seal for sealing the cannula tube when the instrument is received within the cannula tube. The insufflation port is preferably located distally of the at least one seal.
• In certain preferred embodiments, the device comprises the obturator and in others, the device comprises a dissector.
• The obturator may include an elongate body configured to fit within the cannula tube so as to extend partially out the distal end of the cannula tube.
• In another aspect of the present invention, a method of creating an anatomical space within an abdomen and providing subcutaneous access to a body cavity within the abdomen comprises: creating the anatomical space using a dissector inserted into an incision in the body, the dissector being connected to a balloon tip cannula; inserting the balloon tip cannula through the incision, the balloon tip cannula comprising a cannula tube with an anchoring balloon on a distal end thereof and an adapter on a proximal end thereof, the adapter being arranged for connecting with the dissector; detaching the balloon tip cannula from the dissector; inflating the anchoring balloon; engaging the anchoring balloon against an inner surface of the body cavity; sliding the skin seal distally against an outer surface of the body cavity; and removing the dissector and introducing insufflation fluid into the body cavity. Desirably, the step of detaching is performed before the step of inserting the balloon tip cannula and the balloon tip cannula is advanced distally on the dissector. The method may include removing an obturator from the balloon tip cannula and the dissector may be inserted in the balloon tip cannula.
• The skin seal may be secured in place. An endoscope may be inserted into the balloon tip cannula after the step of removing the dissector. The balloon tip cannula desirably includes an anchor inflation port in communication with the anchoring balloon and the method may include the step of deflating the anchoring balloon by opening the anchor inflation port. In a further aspect of the present invention, a method of dissecting tissue and providing subcutaneous access to a body cavity comprises introducing a balloon dissector and balloon tip cannula assembly into an incision. The balloon dissector and balloon tip cannula assembly comprises: i) a balloon dissector including a dissector tube defining a passage and a dissection balloon having an interior and being affixed to a distal end of the dissector tube so that the passage and the interior communicate with one another, the balloon dissector having an inflation port arranged for providing inflation fluid to the passage; ii) a first obturator configured for insertion through the passage and into the interior of the dissection balloon; and iii) a balloon tip cannula having a cannula tube and an anchoring balloon on a distal end of the cannula tube. The method includes: inserting the balloon dissector and balloon tip cannula assembly into the body to a desired location; inflating the dissection balloon so as to dissect tissue along natural tissue planes; deflating the dissection balloon; advancing a distal tip of the balloon tip cannula through the incision to position the anchoring balloon within the body cavity; inflating the anchoring balloon and advancing the skin seal against the outer surface of the body; removing the balloon dissector and first obturator from the balloon tip cannula; and introducing insufflation fluid into the body.
• In certain preferred embodiments, the balloon tip cannula has a second obturator and the method includes the step of assembling the balloon tip cannula and balloon dissector by removing the second obturator and inserting the balloon dissector into the balloon tip cannula. Latching structure on the balloon dissector may be engaged with the balloon tip cannula. The first obturator is removed before the step of deflating and an endoscope is inserted into the dissector tube. The method may include releasing the latching structure from the balloon tip cannula.
• The skin seal is desirably secured against the outer surface of the body. Desirably, the method includes deflating the anchoring balloon. The balloon tip cannula may be removed from the body.
BRIEF DESCRIPTION OF THE DRAWINGS
• Preferred embodiments of the presently disclosed balloon dissector and balloon tip cannula are described herein with reference to the drawings, wherein:
• FIG. 1 is a cross-sectional side view of a balloon dissector assembly according to an embodiment of the present invention;
• FIG. 2 is an exploded perspective view of the balloon dissector assembly in accordance with the embodiment ofFIG. 1;
• FIG. 2A is a cross-sectional view taken along line2A-2A inFIG. 1;
• FIG. 2B is a perspective view of a balloon in accordance with the embodiment ofFIGS. 1-2A.
• FIG. 3 is a cross-sectional side view of a balloon tip cannula assembly according to another embodiment of the present invention;
• FIG. 4 is an exploded perspective view of the balloon tip cannula assembly in accordance with the embodiment ofFIG. 3;
• FIG. 4A is a perspective view of the elongated tube of the balloon tip cannula and inflatable balloon anchor;
• FIG. 4B is a perspective view of the elongated tube of the balloon tip cannula with the inflatable balloon anchor positioned over a distal end;
• FIG. 4C is a view similar to that ofFIG. 4B with opposed ends of the inflatable balloon anchor welded to the elongated tube;
• FIG. 4D is a perspective view of a silicone sleeve and heat shrink tubing for securement over the inflatable balloon anchor;
• FIG. 5 is a cross-sectional side view of a combined balloon dissector with balloon tip cannula according to a further embodiment of the present invention;
• FIG. 6 is a perspective view of the combined balloon dissector with balloon tip cannula in accordance with the embodiment ofFIG. 5;
• FIG. 7 is a cross-sectional view of a further embodiment of a combined balloon dissector and balloon tip cannula;
• FIG. 8 is a perspective view of the combined balloon dissector and balloon tip cannula in accordance with the embodiment ofFIG. 7;
• FIG. 9 is a cross-sectional view of the balloon dissector in accordance with the embodiment ofFIG. 7; and
• FIG. 10 is a cross-sectional view of the balloon tip cannula in accordance with the embodiment ofFIG. 7.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
• Preferred embodiments of the presently disclosed balloon dissector assembly, balloon tip cannula assembly and the combined balloon dissector with balloon tip cannula will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “distal” refers to that portion of the instruments, or component thereof, which is further from the user while the term “proximal” refers to that portion of the instrument, or component, thereof which is closer to the user.
• Referring toFIGS. 1 and 2, aballoon dissector assembly10 according to an embodiment of the present invention is shown.Balloon dissector assembly10 generally has a longitudinal axis-X and includes aballoon dissector12 having anadapter assembly24 and anobturator assembly26.Balloon dissector assembly10 includes adissection balloon14 configured and adapted for inflating in order to separate layers of tissue to form an anatomic space within the body of a patient. Aninflation aperture16 is located in the proximal region ofdissection balloon14 and is dimensioned to receive and be affixed to a distal end of adissector tube18.Dissector tube18 is an elongated tubular structure having open proximal and distal ends defining anaccess passage20 therebetween. Aninflation port22 is located at a proximal end ofdissector tube18 and provides a communicative channel between thepassage20 and a source of inflation pressure.
• It is further envisioned thatdissection balloon14 may be manufactured from a material wherein thedistal region58 includes a substantially transparent section, or window, thereby allowing visual access to the dissected space. Additionally or alternatively,dissection balloon14 may be manufactured from a material that is substantially transparent, also allowing visual access to the dissected space. As inflation pressure is applied,dissection balloon14 desirably expands to a predetermined shape and size. Different shapes and sizes are envisioned with the surgical procedure to be performed determining which shape and size is selected. The dissection balloon can be elastic in all directions, relatively inelastic, selectively elastic in a particular direction such as in its height.
• Referring for the moment toFIGS. 2A and 2B, asleeve cover60 is provided arounddissection balloon14 to retaindissection balloon14 in a collapsed condition during insertion into the body and prior to inflation.Sleeve cover60 may be affixed todissection balloon14, attached todissector tube18 or movably mounted with respect thereto.Sleeve cover60 includes a longitudinal weakenedperforated region21 such that upon inflation ofdissection balloon14 the sleeve separates along the perforations and releasesdissection balloon14. In certain preferred embodiments, thedissection balloon14 has marginal ends11 and13 that are rolled inwardly toward axis X and secured using thesleeve cover60. The sleeve cover is heat sealed at19 to the material of the balloon in the form of twoflaps15,17. After themarginal edges11 and13 are folded or rolled, the flaps of thesleeve cover60 are extended around the rolled balloon and the flaps are heat sealed to one another.Preformed perforation21 in one of the flaps enables thesleeve cover60 to separate upon inflation of the balloon.
• Prior art dissection balloons are generally disposed substantially orthogonal to the longitudinal axis of the device wherein their initial inflation motion aligns them with the longitudinal axis, possibly increasing unintended tissue damage. In the present embodiment, the balloon desirably unrolls or unfolds in a lateral direction.
• Anadapter assembly24 is configured for attachment to the proximal end ofdissector tube18 and generally includes ashroud28 and anend cap30 having a latchingadaptor34 attached to endcap30, as best seen inFIG. 2. Located in a distal region ofadapter assembly24, theremovable shroud28 is dimensioned for surrounding the proximal end ofdissector tube18.Shroud28 is preferably configured in a generally frusto-conical shape wherein a narrow portion surroundsdissector tube18 and a wider portion is adapted for receiving latchingadapter34. Latchingadapter34 includes a pair ofopposed arms36. Eacharm36 is generally flexible and biased to spring return to its starting position. Furthermore, eacharm36 includes adistal hook38 and aproximal lever40. By actuatinglevers40 towards longitudinal axis-X,arms36 pivot about an attachment point causing eachhook38 to rotate generally about its attachment point. When latchingadapter34 is attached toshroud28, hooks38 are in releasable engagement withrecesses41 formed inshroud28.
• The distal end of latchingadapter34 includes a plurality oftabs42 and are configured for affixing latchingadapter34 to aninner wall44 ofend cap30, as best seen inFIG. 1.Inner wall44aofend cap30 surrounds and is affixed to a proximal end ofdissector tube18. A central opening through latchingadapter34 is provided to receive different devices, such as, for example, an obturator or an endoscope, which can be received through theend cap30, latchingadaptor34,shroud28 andtube18, and position these devices within balloontip dissector assembly10. In certain preferred embodiments, the central opening is dimensioned for slidingly receiving devices generally having a diameter of between about 5 and about 10 millimeters, although embodiments for accommodating smaller and larger sizes are contemplated.
• Theadapter assembly24 may comprise one or more parts. In other embodiments, any of theend cap30, latchingadapter34, andshroud28 may be combined in a unitary part. Preferably,shroud28 is ergonomically designed for use by a surgeon and configured to give the balloon dissector a streamlined look. In a preferred embodiment, theend cap30, latchingadapter34 andshroud28 are combined in one integral part attached to a proximal end of thedissector tube18.
• Anadapter orifice46 and a connectingport48 are located onend cap30. Optimally,adapter orifice46 is substantially circular, centrally located onend cap30, and configured to receive devices therethrough. A diameter reducing device (not shown) may be included as well to accommodate devices having a diameter less than a given size. The reducing device would be attached to endcap30 overadapter orifice46 for engaging tubular surgical devices of differing sizes and providing a degree of stability for the surgical devices inserted throughadapter orifice46. Alternatively or additionally, theend cap30 desirably includes a seal for maintaining fluid pressure within the dissection balloon when the obturator or scope is received in the inflation tube and through theend cap30. The connectingport48 is dimensioned for receiving avalve50 in a sealing manner such thatvalve50 is in fluid communication with connectingport48.
• Adissector inflation valve50 is preferably located on a surface ofend cap30 that is readily accessible during a surgical procedure. When dissectorinflation valve50 is attached to endcap30,valve port52 is aligned and in fluid communication withinflation port22 indissector tube18 and therefore in fluid communication withdissection balloon14.Dissector inflation valve50 also includes avalve handle54 that is rotatably attached todissector inflation valve50 wherein internal valve ports (not shown) are configured to permit fluid flow betweenvalve port52 andinflation port22.
• In a preferred embodiment,dissector inflation valve50 is a one-way check valve with a stopcock for inflating and deflatingdissector balloon14. In use, inflation pressure is applied tovalve port52 that is further communicated through the circumferential lumen ofdissector tube18 causingdissection balloon14 to expand. Having a check-valve internal to dissectorinflation valve50 minimizes the loss of inflation pressure throughdissector inflation valve50 thereby allowingdissection balloon14 to maintain its shape and inflation pressure. Advantageously,dissector inflation valve50 includes a stopcock for releasing the inflation pressure. Including a stopcock withdissector inflation valve50 allows the surgical personnel to have better control over the inflation and deflation ofdissection balloon14 since it is integrated intodissector inflation valve50, andvalve50 is readily accessible to the surgical personnel. In other embodiments, a separate deflation device may be provided.
• According to the present disclosure,obturator assembly26 generally includes anobturator body64 having atip66 that is generally conical in shape and is formed the distal end of theobturator body64. Located at the proximal end ofobturator body64 is anobturator flange68. Anobturator cap70 is affixed toobturator flange68. Preferably,obturator cap70 is ergonomically shaped for comfortable use by surgical personnel. In certain preferred embodiments, the obturator comprises a unitary part having an elongated body and a proximal end desirably ergonomically shaped for use by surgical personnel.
• To assemble theballoon dissector assembly10 prior to use,tip66 ofobturator assembly26 is inserted throughadapter orifice46 andobturator assembly26 is advanced distally along longitudinal axis-X. When the underside ofobturator flange68 abutsend cap30, maximum longitudinal travel ofobturator assembly26 is accomplished. Theobturator body64 is sized so that the outer surface ofobturator body64 and the inner surface ofdissector tube18 form aninflation lumen23 betweenvalve port52 anddissection balloon14.
• In order to inflatedissection balloon14, a source of inflation pressure is releasably attached tovalve port52. Valve handle54 is rotated to align the internal valve ports for fluid flow throughdissector inflation valve50. Pressurized fluid is introduced throughvalve port52 and is communicated throughdissector inflation valve50,inflation port22, andinflation lumen23 todissection balloon14. In another alternative, thedissector tube18 terminates at a location distal of thevalve50 and connectingport48 and theinflation port22 is eliminated. Examples of preferred inflation fluids include CO₂, saline solution, or other biocompatible fluids. The pressurized fluid causesdissection balloon14 to expand. In a preferred embodiment,dissection balloon14 is manufactured from a suitable biocompatible material. For example, the balloon may comprise a sheet having a thickness of about 2 mils, or 0.002 inches.
• A method of use forballoon dissector assembly10 as a stand alone device is disclosed. Alternatively,balloon dissector assembly10 can be used with an access port or cannula in the manner described herein below.Balloon dissector assembly10 is shown in an assembled state inFIG. 1. Typically, a suitably sized incision is made in the patient's skin. Next, the assembledballoon dissector assembly10 is inserted into theincision using obturator26 positioned withinballoon dissector12 to tunnel a passage beyond the point of incision, with thedissection balloon14 supported on theobturator body64. Asballoon dissector assembly10 is inserted,dissection balloon14 is restrained bysleeve cover60 and generally surrounds the distal region ofobturator body64 that extends beyond the distal end ofdissector tube18. Preferably,dissection balloon14 is formed from a material that has sufficient strength to minimize damage todissection balloon14 during the tunneling process, but is also has a minimal surface resistance, thereby permitting ease of entrance ofdissection balloon14 into the incision and the surrounding soft tissue.
• Inflation pressure is applied throughvalve port52 from a suitable outside source and is communicated throughdissector inflation valve50 todissection balloon14. As pressure is applied,dissection balloon14 expands and causes theperforated sleeve cover60 to separate alongperforations21, or a weakness in thesleeve cover60 material to break, so as to releasedissection balloon14.Dissection balloon14 unrolls or unfolds laterally and expands vertically to a predetermined shape and size. The vertical expansion of dissection balloon dissects surrounding tissue along natural tissue planes. Once the desired space is created,dissection balloon14 is deflated by operating the stopcock onvalve50 to release the pressure insidedissection balloon14. Alternately, removal ofobturator assembly26 allows the inflation pressure to be relieved through the opening atadapter orifice46.
• Following removal ofobturator assembly26, other suitable configured surgical instruments, or devices may be inserted intodissector tube18. One such example is an endoscope for viewing the dissected space wherein at least a portion of thedissection balloon14 is substantially transparent for viewing the dissected space. In alternative embodiments, theobturator assembly26 may be removed, either before or after theballoon dissector assembly10 is introduced into the body, and the endoscope may be inserted into thedissector tube18 prior to inflation of the dissection balloon. Desirably, theballoon dissector assembly10 is removed after dissection and the dissected space is insufflated, as is known in the art.
• Referring now toFIGS. 3 and 4, there is disclosed a balloontip cannula assembly80 for use as an access port for use with various surgical instruments or in combination withballoon dissector assembly10 as described in more detail hereinbelow. A balloontip cannula assembly80 generally includes aballoon tip cannula82 having aseal assembly84 and anobturator86.
• Balloon tip cannula82 comprises anelongated tube88 that is open at its proximal and distal ends defining anaccess lumen90 for receipt of surgical instruments therethrough. Aproximal lumen port92 and adistal lumen port94 are disposed on an outer surface of thecannula88. Defined between the inner surface and the outer surface oftube88 is aninflation lumen96 extending along longitudinal axis-x and communicating with proximal anddistal lumen ports92,94. Aninflatable balloon anchor98 is disposed in the distal region oftube88. In a preferred embodiment,balloon anchor98 has a generally toroidal shape, is located alongtube88, and enclosesdistal lumen port94 in a substantially fluid-tight sealing manner. Further still,balloon anchor98 is expandable to a predetermined size and shape.
• Referring for the moment toFIGS. 4A to4C,inflatable balloon anchor98 is affixed to a distal end ofelongated tube88 in a novel manner. In order to prepareelongated tube88 to receiveinflatable balloon anchor98, aselective region150 ofelongated tube88 is dipped in a suitable material having characteristics sufficient for adhesion toinflatable balloon anchor98. Preferably,selective region150 is dipped in a urethane material to result in aurethane coating152 overselective region150. In order to attachinflatable balloon anchor98 toelongated tube88,inflatable balloon anchor98 is initially positioned overselective region150 and aboutdistal lumen port94. As best shown inFIG. 4C, opposed ends154 and156 ofinflatable balloon anchor98 are treated to a thermal welding procedure to hot weld opposed ends154 and156 to coating152 on the distal end ofelongated tube88. In this manner,inflatable balloon anchor98 is securely affixed toselective region150 ofelongated tube88.
• Referring toFIG. 4D, in a preferred embodiment, there is provided asilicone sleeve158 which is configured to be positioned aboutinflatable balloon anchor98.Silicone sleeve158 is secured aboutinflatable balloon98 by a pair ofrings160 and162 which are positioned about opposed ends164 and166 ofsilicone sleeve158. Preferably, rings160 and162 are formed of a heat shrinkable material such that whensilicone sleeve158 is positioned overinflatable balloon anchor98 and heat shrink rings160 and162 are positioned about opposed ends164 and166 ofsilicone sleeve158, rings160 and162 may be subjected to a heat treatment which will shrinkrings160 and162 thereby securingsilicone sleeve158 overinflatable balloon anchor98. Therings160 and162 serve to reinforce theballoon anchor98 at its proximal and distal ends. Thesleeve158 may comprise a sleeve of any resilient, bio-compatible material. Furthermore, other methods may be used to attach theballoon anchor98 to thetube88, such as by adhering theballoon anchor98 to thetube88, such as by adhering theballoon anchor98 to thetube88. In further alternatives, theballoon anchor98 may be suture-tied to the balloon and coated with RTV.
• Referring toFIG. 4, in a preferred embodiment,balloon tip cannula82 further includes askin seal100 slidably attached to the outside oftube88.Skin seal100 desirably includes afoam collar102 and a securing means104 for securing the skin in a desired longitudinal position along longitudinal axis-x. A suitable skin seal is disclosed in International Publication No. W002/096307 entitled Balloon Cannula with Over Center Clamp, the entire disclosure of which is hereby incorporated by reference herein. Whenballoon tip cannula82 is inserted through an incision in the patient's skin,skin seal100 is moved into position against the skin surface of the patient's body forming a pressure barrier, thereby minimizing the loss of inflation pressure through the opening in the patient's skin, and in combination withanchor balloon98, securesballoon tip cannula82 to the patient's body.
• Balloon tip cannula82 additionally includes anadapter flange106 having proximal and distal openings defining a bore therebetween. On one surface ofadapter flange106 is avalve port108 dimensioned to receive avalve110 in a substantially fluid-tight sealing manner. The distal end ofadapter flange106 is dimensioned to receive and be affixed to the proximal end ofcannula tube88 in a substantially fluid-tight sealing manner. When the proximal end ofcannula tube88 is fully inserted in the distal end ofadapter flange106,valve port108 is aligned withproximal lumen port92, and thereby aligned withvalve110. Located near the proximal end ofadapter flange106 are a pair ofrecesses112 each having a generally rectangular configuration and preferably diametrically opposed to one another.Recesses112 are configured to receive a latching structure associated withobturator128 as described hereinbelow. Alternatively, when used in combination withballoon dissector12 as described hereinbelow, recesses112 provide attachment points for latchingadaptor34. In other embodiments, no latching structure is used between theballoon dissector assembly10 and balloontip cannula assembly80.
• Balloon tip cannula80 preferably employs a one-way check valve having a stopcock for inflating and deflatinganchor98. Ananchor inflation valve110 is preferably located on a surface ofadapter flange106 that is readily accessible during a surgical procedure. Whenanchor inflation valve110 is attached toadapter flange106,valve port114 is aligned and in fluid communicationproximal lumen port92 and therefore in fluid communication withballoon anchor98.Anchor inflation valve110 also includes avalve handle116 that is rotatably attached to anchorinflation valve110 wherein internal valve ports (not shown) are configured to permit fluid flow betweenvalve port114 andproximal lumen port92. In other embodiments, a separate deflation device may be provided.
• In order to inflateballoon anchor98, a source of inflation pressure is releasably attached tovalve port114. Valve handle116 is rotated to align the internal valve ports for fluid flow throughanchor inflation valve110. Pressurized fluid is introduced throughvalve port114 and is communicated throughanchor inflation valve110,proximal lumen port92, andinflation lumen96 toballoon anchor98. Examples of preferred inflation fluids include CO₂, saline solution, or other biocompatible fluids. The pressurized fluid causesballoon anchor98 to expand. In a preferred embodiment,anchor inflation valve110 is a one-way check valve with a stopcock. Having a check-valve internal to anchorinflation valve110 minimizes the loss of inflation pressure throughanchor inflation valve110 thereby allowingballoon anchor98 to maintain its shape and inflation pressure. Advantageously,anchor inflation valve110 includes a stopcock for releasing the inflation pressure. Including a stopcock withanchor inflation valve110 allows the surgical personnel to have better control over the inflation and deflation ofballoon anchor98 since the stopcock is mounted onanchor inflation valve110 where it is readily accessible to the surgical personnel. However, separate inflation and deflation devices may be provided on the balloon tip cannula.
• Aninsufflation port120 is provided onadapter flange106 and in fluid communication with the interior ofadaptor flange106 and interior oftube88 to provide insufflation fluid to the interior of a patient's body.
• Seal assembly84 generally includes aduckbill seal122 configured and adapted to be received by the interior surface ofadapter flange106 wherein the outer surface ofduckbill seal122 and the interior surface ofadapter flange106 mate in a substantially fluid-tight sealing manner.Duckbill seal122 functions in conventional manner to seal balloon tip cannula in the absence of an instrument having been inserted into the balloon tip cannula, and provide a seal against the escape of insufflation fluid. Whileduckbill seal122 is shown closed inFIG. 3 withobturator86 in place, it is to be understood thatduckbill seal122 would only be closed in the absence of an instrument therethrough. An opening is located at the proximal end ofduckbill seal122 for receiving anadapter ring124.Adapter ring124 is sized for snug engagement withduckbill seal122 and includes a substantially central orifice dimensioned to receive a surgical device, such as an obturator and provides a seal around such surgical device. Further still,adapter ring124 is maintained in position within the proximal region ofduckbill seal122 by aretainer ring126 having a central opening substantially equal to the opening ofadapter ring124. A reducing device as described hereinabove with respect toballoon dissector12 may be included as well to accommodate various diameter instruments. The reducing device is attached toretainer ring126 for slidably engaging tubular surgical devices of differing sizes and providing a degree of stability for the surgical devices inserted throughretainer ring126. Although theduckbill seal122 andring124 are shown in this embodiment, other embodiments include seals having different configurations. Desirably, the balloontip cannula assembly80 include both a seal for sealing the interior oftube88 in the absence of instruments that may be received in the assembly, as well as a seal for sealing against an instrument, once inserted into the assembly.
• Balloontip cannula assembly80 further includesobturator86 for facilitating insertion of balloon tip cannula through an incision in a patient's body.Obturator86 generally includes aobturator body128, acap130 affixed toobturator body128 and a latchingadapter132 affixed to cap130 and surroundingobturator body128. In further embodiments, the latchingadapter132 is eliminated and latches are incorporated oncap130.Obturator body128 is generally elongate and cylindrical and has a roundedobturator tip134 located at the distal end ofobturator body128.Obturator body128 includes anobturator adapter136 disposed at its proximal end.
• Latchingadapter132 is attached to cap130 in a manner similar to that described above with respect to the latching adapter ofballoon dissector12.Obturator adaptor136 is affixed to an inner surface ofcap130. Latchingadapter132 is generally circular in configuration having a throughbore. A plurality ofresilient tabs138 are located at the distal end, eachtab138 being separated from each other tab by a slot. In addition, eachtab138 is biased towards the center of the throughbore for engagement withcap130 in a manner similar to that discussed above with respect to latchingadapter34 andend cap30. Located near the proximal end of latchingadapter132 is a pair of diametricallyopposed arms140. Eacharm140 is pivotably attached to latchingadapter132 whereupon eacharm140 rotates about a pivot point substantially perpendicular to longitudinal axis-x. Preferably, eacharm140 is biased in a starting position, is capable of rotation away from the other arm, and includes ahook142 at its distal end wherein eachhook142 is configured to releasably mate withrecess112 ofadapter flange106.
• Whenobturator86 is inserted and advanced along longitudinal axis-x through retainingring126,adapter ring124,duckbill seal122, and throughtube88, latchingadapter132 is advanced distally and hooks146 approach and engagerecesses112. Preferably, thearms140 are biased toward a latching position and deflect inwardly, then snap into engagement withrecesses112. The operator may rotatearms140 by movinglevers144 in a generally outward direction, thereby causinghooks142 to rotate generally inwards. Afterobturator86 is fully inserted intoballoon tip cannula82, the operator releaseslevers144, thereby allowingarms140 to return their starting position. In the starting position, hooks142 engagerecesses112 to retain latchingadapter132 andobturator86 in position. In addition, when the assembled structure is fully inserted,obturator tip134 extends beyond the distal end oftube88.
• Cap130 includes a pair ofgrooves146 configured and adapted for slidably receivingarms140. It is preferred thatcap130 be configured for ergonomic efficiency whereby the operator can usecap150 with a minimum of effort or discomfort.
• In certain preferred embodiments, thecap130, latchingadapter132 andobturator body128 may be combined in a unitary structure. Theobturator body128 may be provided with a proximal end without latching engagement with theadapter flange106.
• A method of using balloontip cannula assembly80 is disclosed. An incision is made in the skin of the patient in the area of interest. Using the assembled balloontip cannula assembly80, the surgeon advancesobturator tip134 and the distal end of balloontip cannula assembly80 into the incision, thereby positioning balloontip cannula assembly80 into the area of interest.
• Once balloontip cannula assembly80 is positioned, inflation fluid is applied throughvalve port114 andvalve port108 thereby communicating the inflation pressure toproximal lumen port92. Since proximal anddistal lumen ports92,94 are in direct fluidic communication with each other throughinflation lumen96, inflation fluid is transferred todistal lumen port94 and therefore toballoon anchor98. As inflation fluid is applied toballoon anchor98, it expands to reach its predetermined shape. After theanchor balloon98 is expanded, it abuts the underside of the patient's skin to hold balloontip cannula assembly80 in position. Preferably,balloon anchor98 has a shape for anchoring the balloontip cannula assembly80, such as the toroidal shape shown and is of sufficient size to holdcannula80 in a desired position. It is contemplated that the balloon anchor may have any other shape.
• After balloontip cannula assembly80 is located through the incision andballoon anchor98 expanded,skin seal100 is advanced distally alongcannula tube88 until it is in an abutting relationship with the outer surface of the patient's body such thatfoam collar102 is compressed and means for securing104 theskin seal100 are actuated to lock skin seal againstcannula tube88.
• Once balloontip cannula assembly80 is anchored in position, levers144 are rotated outwards causingarms140 to rotate inwards, thereby disengaginghooks142 fromrecesses112. Afterhooks142 are disengaged fromrecesses112,obturator86 is retracted fromballoon tip cannula82 while the surgeon holdsballoon tip cannula82 in position, thereby separating the components. Afterobturator86 is completely removed, other surgical structures may be installed inballoon tip cannula82 to access the surgical site. Examples of such surgical instruments include, but are not limited to, endoscopes, graspers, shears, surgical suturing devices, and surgical device applicators.
• Upon completion of the surgical procedure, the surgeon deflatesanchor balloon98 by operatingvalve110. Inflation pressure held byanchor balloon98 exits the system throughvalve port114 by reversing the flow path for inflation. Onceanchor balloon98 is sufficiently deflated,balloon tip cannula92 is removed from the surgical site. The silicone sleeve over theanchor balloon98 resiliently applies pressure against the balloon, tending to deflate the balloon as the valve is opened. After removal, the incision may be sutured closed, or other surgical structures may be used at the incision site for additional surgical procedures.
• Referring now toFIGS. 5 and 6, and as noted above,balloon dissector assembly10 andballoon tip cannula80 can be used separately as individual instruments in the manner described hereinabove or preferably, and more advantageously, can be combined together to form a combined balloon dissector withballoon tip cannula200. This allows the surgeon to eliminate operational steps when creating an anatomical space within a body. Balloon dissector withballoon tip cannula200 includes components of balloon dissector above and balloon tip cannula above. Each of these instruments are designed so as to be easily combined into a single instrument.
• Referring now toFIGS. 5 and 6, the combinedassembly200 has theballoon dissector12 andobturator assembly26 inserted through retainingring126 andduckbill valve122 of theballoon tip cannula82 such thatdissection balloon14 anddissector tube18 are advanced throughcannula tube88 ofballoon tip cannula82. Theballoon dissector12 desirably has a latchingadapter34 that engagesrecesses112 in anadapter body106 ofballoon tip cannula82 to securely lockballoon dissector12 toballoon tip cannula82. However, in other embodiments, no connecting structure is provided. Once assembled, the combined balloon dissector withballoon tip cannula200 is ready to be used to create an anatomical space within a body cavity within a patient's body and provide a secured access port for receipt of surgical instruments.
• In use, an initial incision is made through the abdominal wall of a patient's body. The combined balloon dissector withballoon tip cannula200 is positioned such thatdissection balloon14, supported byobturator assembly26, is inserted through the incision. The combined device is advanced through the incision untildissection balloon14 is at a desired location. At this point,obturator assembly26 may be removed and a endoscope inserted therein.
• Once in a proper position, a source of inflation fluid is connected tovalve port52 ofdissector inflation valve50 and inflation fluid is forced through connectingport48 and thelumen23 defined by the inner surface oftube18 and the outer surface ofobturator26. The inflation pressure forces dissectorballoon14 to start to expand which forces perforations21 of sleeve cover60 (FIG. 2) to separate to thereby release the balloon. As noted above, the balloon is typically in a rolled up configuration and as it unfurls it unrolls or unfolds laterally and expands vertically relative to the plane of the balloon to separate tissue layers along natural tissue planes to form an anatomical space for a surgical procedure.
• Once the tissue has been dissected and the anatomical space formed,dissection balloon14 can be deflated by openingdissector inflation valve50 to release the inflation pressure or by removingobturator assembly26 thereby opening theadapter orifice46 to theinflation lumen23, which is defined betweenobturator26 and the inner surface ofdissector tube18. Onceballoon14 has been deflated, theballoon dissector assembly10 is disconnected from theballoon tip cannula82 by depressinglevers40 thereby releasinghooks38 on latchingadaptor34 fromrecesses112 inadapter body106. Theballoon tip cannula82 is slid down thetube18 ofballoon dissector assembly10 and theballoon tip cannula82 is advanced through the incision to positionballoon anchor98 within the abdominal wall. A source of inflation fluid is connected tovalve110 to inflateballoon anchor98. Onceballoon anchor98 has been inflated, the user applies a slight proximal tension on the combined device so as to draw anchor balloon against the inner surface of the abdominal wall. The skin seal100 (FIG. 4) is slid distally alongcannula tube88 to compressfoam102 against an outer surface of abdomen and, upon actuating the securing means104 ofskin seal100,cannula82 is securely locked to the abdominal wall, sealing the incision against escape of insufflation fluid.
• Theballoon dissector assembly10 is then removed fromballoon tip cannula82. Once balloon dissector has been removed,duck bill valve122 is in a closed position to form a seal in the proximal end ofballoon tip cannula82. Thereafter, a source of insufflation fluid is connected to insufflationport120 and fluid forced throughballoon tip cannula82 into the body to insufflate and expand the space. Once a space has been created with the insufflation fluid, additional instruments including endoscopes, graspers, tackers, staplers, etc. may be inserted through balloon tip cannula to perform an operation such as, for example, a hernia repair procedure, within a patient.
• In alternative embodiments, theobturator assembly26 may be removed, either before or after theballoon dissector assembly10 is introduced into the body, and an endoscope may be inserted into thedissector tube18 prior to or after inflation of the dissection balloon.
• Once a procedure has been completed, insufflation fluid is withdrawn from the body throughinsufflation port120 andanchor inflation valve110 is opened to allow the inflation fluid to exit fromanchor balloon98. The silicone sleeve of theanchor balloon98 provides pressure tending to deflate theanchor balloon98.Balloon tip cannula82 is then removed through the incision and the incision and the incision is closed in a normal manner.
• Prior art dissection methods generally include inserting a first device, typically a type of dissector, into the patient through an incision at the surgical site whereupon the surgical personnel will dissect the separated tissues. Then a second device, typically a trocar cannula is used to insufflate, maintaining a working space.
• Using a combination device including aballoon tip cannula82 and aballoon dissector12 minimizes the number of procedural steps required to dissect and insufflate. Furthermore, theballoon tip cannula82 includes a skin seal and balloon anchor for anchoring theballoon tip cannula82 and sealing the incision. Ports for inflating thedissection balloon14 andballoon anchor98 are provided. Theballoon anchor98 is easily deflated, as thesleeve158 biases theballoon98 towards deflation. Separate deflation mechanisms are not required, but may be provided. The combineddevice200 includes a passage for receiving an endoscope so that dissection may be observed.
• Referring toFIGS. 7 and 8, an alternate embodiment of a balloon dissector andcannula assembly210 is shown and has aballoon dissector assembly212 and a balloontip cannula assembly213.Balloon dissector assembly212 has an elongatedtube218 having a distal end and a proximal end and defining apassage220. Adissection balloon214ais affixed to the distal end oftube218.Dissection balloon214aforms a chamber that communicates withpassage220.Dissection balloon214ais round and expands to a shape that follows the path of least resistance in tissue. Thedissection balloon214amay have other shapes, such as oblong, kidney shaped, etc.
• Referring toFIGS. 8 and 9, a dissector housing230 is formed on the proximal end oftube218. The dissector housing230 has an orifice at a proximal end and includes a seal. Dissector housing230 may be formed of two parts to support the seal. Dissector housing230 defines an inflation port222 dimensioned for receiving a one-way inflation valve. The inflation valve and inflation port222 communicate withdissection balloon214athroughtube218.
• Anobturator226 having adistal tip266 is received through the orifice in the dissector housing230, throughpassage220 intube218, and into the chamber ofdissection balloon214a. The outer surface ofobturator226 and the inner surface oftube218 form an inflation lumen between inflation port222 anddissection balloon214a. The proximal end ofobturator226 has acap229 which carriesresilient latches231 connected tobuttons233. Whenobturator226 is received in dissector housing230 and advanced intotube218,distal tip266 engagesdissection balloon214aand supports it in a collapsed, elongated shape (not shown). The latches engage recesses on dissector housing230.Additional latches232, connected tobuttons234, are provided on dissector housing230 for interconnecting dissector housing230 tocannula housing306 of balloontip cannula assembly213.
• In order to inflatedissection balloon214a, a source of inflation pressure is releasably attached to inflation port222 and pressurized fluid is introduced through inflation port222 and communicated throughinflation tube218 todissection balloon214a.
• Referring toFIGS. 8 and 10, balloontip cannula assembly213 has acannula300 which is open at its proximal and distal ends to define an access lumen302 for receipt of surgical instruments therethrough. Aninflatable balloon anchor304, having a generally toroidal shape, is disposed in the distal region ofcannula300. As with prior embodiments, theballoon anchor304 is formed by dipping the cannula into a urethane coating and then using thermal welding to attach a urethane membrane to the coated cannula. The membrane is then coated with RTV and heat shrink tube collars reinforce the sleeve at the welded ends. Alternatively, theballoon anchor304 may be attached as discussed above in connection withFIGS. 4A-4D.
• Acannula housing306 is attached to cannula300 at a proximal end ofcannula300.Cannula housing306 has an orifice that communicates with access lumen302. Avalve port308 is provided in a surface ofcannula housing306.Valve port308 is dimensioned to receive a check valve in a substantially fluid-tight sealing manner. Aninflation lumen311 is defined between the inner surface and the outer surface ofcannula300 and extends toballoon anchor304. The check valve communicates withballoon anchor304, through the lumen in the wall of the cannula.
• In order to inflateballoon anchor304, a source of inflation pressure is releasably attached to the check valve, introducing pressurized fluid throughvalve port308 toballoon anchor304, which causesballoon anchor304 to expand.
• Aninsufflation port314 is also provided oncannula housing306, and in fluid communication with the interior ofcannula housing306 andcannula300, to provide insufflation fluid to the interior of a patient's body.
• A seal assembly is provided in thecannula housing306 for sealing the interior ofcannula300 during insufflation. The seal assembly generally includes a seal for sealing around instruments inserted intocannula300 and a seal for sealingcannula300 in the absence of any instruments inserted intocannula300. These seals may be the seals discussed above in connection withFIG. 3.
• Askin seal316 is slidably mounted on the outside surface ofcannula300.Skin seal316 includes acompressible foam collar318 and aclamp320 for securing the skin seal in a desired longitudinal position along the cannula. Theskin seal316 may be as discussed above in connection withFIG. 4.
• Referring toFIG. 10, anobturator323 having aproximal cap324 and adistal end325 is inserted in the orifice ofcannula housing306, and advanced through lumen302 ofcannula300, so thatdistal end325 extends out of the distal end ofcannula300.Cannula housing306 hasrecesses329 for receivinglatches327 onproximal cap324 ofobturator323.Proximal cap324 also carriesbuttons331 for disengaging the latches. To assemble theballoon dissector assembly212 and balloontip cannula assembly213,obturator323 is removed fromcannula300.Balloon dissector assembly212 is inserted into the orifice ofcannula housing306 and advanced through lumen302 ofcannula300 so that latches232 on dissector housing230 are engaged withcannula housing306, inter-connecting the assemblies.
• Theballoon dissector assembly212 is used for dissecting tissue along natural tissue planes in general, laparoscopic, vascular, endoscopic, plastic or reconstructive surgery. A suitably sized incision is made in the patient's skin. Next, the assembled balloon dissector andcannula assembly210 is inserted into the incision, using theobturator226 to tunnel a passage beyond the point of incision.
• Inflation pressure is supplied through inflation port222 from a suitable outside source and is communicated todissection balloon214a. As pressure is applied,dissection balloon214aexpands. The expansion of dissection balloon dissects surrounding tissue along natural tissue planes. Once the desired space is created,dissection balloon214ais deflated by removal ofobturator226 which allows the inflation pressure to be relieved through the orifice in the dissector housing230.
• In an alternative method,obturator226 is removed fromtube218 and replaced with an endoscope. Then,balloon dissector assembly212 is inserted into the skin incision anddissector balloon214ais inflated as discussed above. The scope is used for viewing the dissected space and for viewing during dissection. The endoscope may be inserted intotube218 before or after dissection.
• Afterdissection balloon214ais deflated,cannula housing306 is unlatched from dissector housing230 by pressingbuttons234 on dissector housing230.Cannula300 is advanced alongballoon dissector tube218 and positioned within the incision so thatballoon anchor304 is located inside the body cavity. Inflation fluid is supplied throughvalve port308 thereby communicating the inflation fluid toballoon anchor304 at the distal end ofcannula300, expandingballoon anchor304. Afteranchor balloon304 is expanded, it is brought into engagement with the underside of the patient's abdominal wall.
• Skin seal316 is moved into position against the surface of the patient abdominal wall and secured using the clamp.Skin seal316 forms a pressure barrier, thereby minimizing the loss of insufflation pressure through the opening in the patient's abdominal wall and, in combination withanchor balloon304, securesballoon tip cannula300 to the patient's body.
• Balloon dissector assembly212 is removed fromcannula300 and surgical instruments are introduced to the surgical site throughcannula300. Examples of such surgical instruments include, but are not limited to, endoscopes, surgical suturing devices, and surgical manipulation devices, etc.
• Upon completion of the surgical procedure, the surgeon deflatesanchor balloon304 by releasing the check valve attached tovalve port308. Onceanchor balloon304 is sufficiently deflated,cannula300 is removed from the incision.
• Theballoon dissector assembly212 may be provided with a second type of dissection balloon which is a laterally extending oval balloon. The oval balloon and/or round balloon may comprise an elastic or inelastic material. The elastic material will tend to follow the path of least resistance in the patient's body, whereas the inelastic balloon tends to expand to a predetermined shape. The selection of the type of balloon is left up to the surgeon.
• The oval dissection balloon214bdesirably has an initial collapsed configuration, with the lateral margins of balloon214brolled inwardly towardobturator226 ofballoon dissector assembly212, similar to the rolled configuration discussed above in connection withFIG. 2A.Obturator226 desirably has two recessedflats340, one on each of the lateral sides ofobturator226, for accommodating the rolled margins of balloon214b(FIG. 9). A sleeve (not shown) is provided around dissection balloon214bto retain dissection balloon214bin a collapsed condition during insertion into the body and prior to inflation. The sleeve comprises a sheet of polymeric material that may be attached to the material of the balloon214b, as discussed above. The sleeve includes a longitudinal weakened perforated region such that, upon inflation of dissection balloon214b, the sleeve separates along the perforations and releases dissection balloon214b. As the balloon is inflated, the balloon unrolls or unfolds in a lateral direction with respect to thetube218.
• Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the disclosure. All such changes and modifications are intended to be included within the scope of the disclosure.

Claims (14)

1. A surgical instrument comprising:

a balloon dissector having a dissector housing, a dissector tube extending distally from the dissector housing and a dissection balloon mounted on a distal end of the dissector tube;

a cannula having a cannula housing and a cannula tube extending distally from the cannula housing, the cannula housing having a balloon anchor at a distal end of the cannula tube; and

one of the dissector housing and cannula housing having latching structure and the other of the dissector housing and cannula housing having a recess for receipt of the latching structure.

2. The surgical instrument as recited inclaim 1, wherein the cannula housing includes the latching structure and the dissector housing includes the recess for receipt of the latching structure to removably secure the cannula housing and dissector housing together.

3. The surgical instrument as recited inclaim 1, wherein the latching structure includes at least one movable arm.

4. The surgical instrument as recited inclaim 3, wherein the at least one movable arm include a hook engageable with the recess.

5. The surgical instrument as recited inclaim 1, further comprising a shroud removably attachable to the cannula housing.

6. The surgical instrument as recited inclaim 1, further comprising an end cap removably attachable to the dissector housing.

7. The surgical instrument as recited inclaim 1, further comprising a sleeve surrounding at least a portion of the balloon anchor, the sleeve tending to bias the balloon anchor towards deflation, the cannula housing having a valve in communication with the balloon anchor.

8. A balloon tip cannula comprising:

a cannula housing;

a cannula tube extending distally from the cannula housing;

an anchoring balloon, opposed ends of the anchoring balloon being affixed to the cannula tube; and

a sleeve surrounding at least a portion of the balloon anchor, the sleeve tending to bias the balloon anchor towards deflation.

9. The balloon tip cannula as recited inclaim 8, wherein the anchoring balloon is formed of a urethane material.

10. The balloon tip cannula as recited inclaim 8, further comprising a ring positioned about each opposed end of the sleeve.

11. The balloon tip cannula as recited inclaim 10, wherein each ring is formed of a heat shrinkable material.

12. A method of securing an anchoring balloon to a cannula tube comprising:

affixing opposed ends of an anchoring balloon to a cannula tube; and

disposing a sleeve around the anchoring balloon.

13. The method as recited inclaim 12, wherein the flexible sleeve is secured over the anchoring balloon by bands applied about opposed ends of the sleeve.

14. The method as recited inclaim 13, wherein the bands are formed of a heat shrinkable material and are heat shrunk about the opposed ends of the sleeve to secure the sleeve over the anchoring balloon.

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